Sawis

Medicinal product

(Invented) name

Sawis

Active substance (s)

Dienogestas

Strength

2 mg

Pharmaceutical form

tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

G03DB08, Dienogest

Marketing authorisation holder

Gedeon Richter Plc, Vengrija

Date of authorisation

2019-03-04

Date of renewal

2025-01-31

Documents

4338_Sawis_perr2025-01-31.docx

4338_pakuotes lapelis_2025-01-31.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

HU/H/0532/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Dienogestas	2 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
101022	87133	1087133	lizdinė plokštelė	N28		Receptinis	LT/1/19/4338/001	Tiekiama	-	-	No	-	-	Download
101023	87134	1087134	lizdinė plokštelė	N84		Receptinis	LT/1/19/4338/002	Netiekiama	-	-	No	-	-
101024	87135	1087135	lizdinė plokštelė	N168		Receptinis	LT/1/19/4338/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-01-31	Perregistruotas
2019-03-04	Registruotas